Location: St. Paul, MN
Duration: 6+ months
Under the direction of the Clinical Evaluation Report Project Manager (CER PM) and Director, will be asked to perform the following:
- Author, review, quality control, and/or provide feedback, in accordance with client processes and procedures, documents related to clinical evaluation of medical device products including: Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post-Market Surveillance (PMS) Plan, Post-Market Clinical Follow-up (PMCF) Plan, PMCF Report, Summary of Safety and Clinical Performance (SSCP).
- Document editing and quality control, generally include: quality review of accurate data presentation and bibliography, ensuring correctness of document content, preparing finalized documents for submission to document control, and managing literature screening projects with DistillerSR and EndNote.
- Request PMS data and reports, and further analyze and synthesize these data and reports.
- Summarize and synthesize other sources of data relevant to safety and performance of products, including: pre-clinical data reports, risk management assessment reports, published clinical literature, clinical investigation results and field performance data.
- Interface regularly with the CER PM, and may interact with stakeholders from key functional areas (e.g., clinical team, EU and US regulatory, R&D, risk management, etc.) to obtain necessary information and documents (e.g., technical files, risk reports, IFU, etc.) required for CER content.
- Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment.
- Other relevant duties as required
- Bachelor’s degree required; Master’s or PhD preferred with a focus in science, engineering, or medical fields.
- 2+ years of experience in a medical, clinical research, quality systems setting; regulatory experience in medical device or pharmaceuticals industry is preferred.
- MUST have CER or MDR writing experience; preferably with Class III and/or implantable devices.
- Understanding of regulations, standards and guidelines related to medical devices, clinical studies, and quality systems, including: 21 CFR (e.g., 803, 812, 814, 820, 822, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
- Effective written, verbal and presentation skills in English.
- Strong command of medical terminology.
- Highly-developed interpersonal skills, and strong attention to detail.
- Experienced with MS Office suite